Complaint-Handling, MDR and Recall Management: Panel

Global
CompliancePanel
Knowledge, a Way Forward
2-day In-person Seminar:
Complaint-Handling, MDR and Recall Management
Los Angeles, CA
October 22nd & 23rd, 2015
9:00 AM to 6:00 PM
Course "Complaint-Handling, MDR and Recall Management" has been pre-approved by RAPS
as eligible for up to 12 credits towards a participant's RAC recertication upon full completion.
David R. Dills
Regulatory Affairs & Compliance Consultant,
David R. Dills Regulatory Affairs & Compliance Consultant currently provides regulatory affairs, compliance and quality
consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, and bio/pharmaceutical
manufacturers on the global landscape, and also has an accomplished record with more than 25 years of experience in the
areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing
responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked
directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA's,
warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts QS and
regulatory audits.
Overview
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should
understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and
analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether
the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further
occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or
manufacture of a product.
Global
CompliancePanel
Agenda:
DAY ONE
Continue......
What are the elements of an effective complaint
management system?
Records and trend analysis

Complaint closure
How does risk management inuence complaint
handling decisions?
Examples of tools currently being used to conduct
investigations
What are the responsibilities of other departments?

What is the best way to train customer contact
employees?
How far and in-depth do you go with your
investigations
What are current FDA "hot" buttons and trends,
What steps would the FDA expect to see the
departments taking that sorts out potential MDRs,

product complaints and other reportable events?
What and how do you perform trending?
What are examples of how companies trend and
analyze service calls and product complaints?
benchmarks and best practices for investigations

How to become a "good" investigator and the
emphasis on closed-loop investigations

Written Procedures: Designated Complaint
Handling Unit, Training and Records

Recent Enforcement Actions
Understand how and why CAPA is tied in to product
complaint investigation
What is an appropriate complaint handling system
in a risk-based post-market environment?

How do you audit a complaint handling system?
From your audits, how do you judge that your
complaint handling system is effective?

Assignment of responsibility
Manufacturer should develop a method for
maintaining records of complaints and
Introduction to Medical Device Reporting

What are the key terms, denitions and forms?
MDR procedures and processes
What are the requirements for developing,
maintaining, and implementing written MDR

procedures that apply to me?
How do you manage international reporting
investigations that: is functional and economical,
requirements under your complaint handling
meets company needs, and meets FDA
system?
requirements and expectations
Consider the relationship between MDRs and Risk
Identify designated complaint handling unit

Instructions for documenting complaint information
Assessments
Process for evaluating complaints

Process for investigating complaints
Identify and process MDR's
How to process customer returns
Exercise on Product Complaints/Complaint
Handling
Quiz
Why you should attend

Understand that although FDA does not specify a standard complaint handling system, the requirements do specify certain actions that
shall be included in any system

Grasp and comprehend the denitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting
and handling of Recalls

All personnel who deal with customers, or who may receive a complaint call, must be trained in the proper routing/handling of com-
plaints
Global
CompliancePanel
Agenda:
DAY TWO
Continue......
eMDR Electronic Medical Device Reporting
Who should be responsible for communicating with
How to Report a Problem
FDA?
Event Problem Codes and Manufacturer Evaluation
Codes
What are the consequences of a recall?

What factors should you consider when determining
MedWatch: Safety Information and AER Program
whether or not to get your product back?
Completing Form FDA 3500A
How do you prepare for a post recall inspection?
What form should I use to submit reports of
What customer and other outside communications
individual adverse events and where do I obtain

these forms?
are necessary?
What documentation should be prepared?
Where and how do I submit reports and additional
information?
How should the product liability implications of
recall communications be handled?
Does the information in my report constitute an
What is an effectiveness check?
admission that the device caused or contributed to
Health Hazard Evaluations are conducted by FDA
the reportable event?
How should you write your recall correspondence?
What are the requirements for developing,
How do you determine that your recall is completed
maintaining, and implementing written MDR
and what do you do to close your recall internally
procedures and maintain records/les that apply to
and with FDA?
me?
Create and use a recall operational
Requirements for Individual Adverse Event Reports

User Facility Reporting, Importer Reporting and
Manufacturer Reporting Requirements
Understand what is required for the recall strategy
as expected by FDA
Depth of recall and using a viable, sustainable and
effective strategy
Understand why the documentation and paper trail
What happens in a medical device recall: Firm-
initiated recall vs. mandatory recall
are so critical and termination of a recall

Discuss most recent recalls not only for devices but
What information needs to be reported?
pharmaceuticals and why the numbers are alarming
What types of records do companies need to keep?

Prior to notifying FDA, what steps should you have
Exercise - MDR and Recall
taken?
What are the dos and don'ts when informing FDA of
Quiz
a product problem?
Who should be involved in the decision process?
Areas Covered in the Session

Reporting complaints
Managers
What types of Reports does the FDA receive and who must submit Mandatory
Reports to the FDA?
Complaint evaluation and investigation
Who can submit Voluntary Reports to the FDA?
Data collection and trending
How Does the FDA Use Medical Device Reports?
CAPA process for investigating complaints
Medical Device Recall Reporting
Understand the History of MDR Regulation
Recall Responsibilities & Requirements
Global
CompliancePanel
Pricing List
Group participations
Price for One Delegate pass Price: $ 1,295.00

Register now and save(Early Bird) $200.(Early Bird) Price
Register Now
**Please note the registration will be closed 2 days (48 Hours) prior to
2 Attendees to get offer
10%
3 to 6 Attendees to get offer
20%
7 to 10 Attendees to get offer
25%
10+ Attendees to get offer
30%
the date of the seminar.
What you will get

Learning Objectives
Participation certificates
Payment Option
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Visa/Master/American Express card click on the
register now link
Interactive sessions with the US expert

Post event email assistance to your queries.
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NetZealous DBA GlobalCompliancePanel and
mailed to 161 Mission Falls Lane, Suite 216,
Special price on future purchase of web
Fremont, CA 94539, USA
based trainings.
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Special price on future seminars by
GlobalCompliancePanel.
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Networking with industry's top notch professionals
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Look forward to meeting you at the seminar
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Global

Knowledge, a Way Forward

2-day In-person Seminar:

Complaint-Handling, MDR and Recall Management

October 22nd & 23rd, 2015

Knowledge, a Way Forward

What are the elements of an effective complaint

Records and trend analysis

How does risk management inuence complaint

Examples of tools currently being used to conduct

What are the responsibilities of other departments?

How far and in-depth do you go with your

What steps would the FDA expect to see the

departments taking that sorts out potential MDRs,

analyze service calls and product complaints?

benchmarks and best practices for investigations

emphasis on closed-loop investigations

Handling Unit, Training and Records

Understand how and why CAPA is tied in to product

in a risk-based post-market environment?

complaint handling system is effective?

maintaining records of complaints and

Introduction to Medical Device Reporting

maintaining, and implementing written MDR

investigations that: is functional and economical,

requirements under your complaint handling

meets company needs, and meets FDA

requirements and expectations

Consider the relationship between MDRs and Risk

Identify designated complaint handling unit

Process for evaluating complaints

Exercise on Product Complaints/Complaint

Why you should attend

shall be included in any system

and handling of Recalls

Knowledge, a Way Forward

eMDR Electronic Medical Device Reporting

Who should be responsible for communicating with

How to Report a Problem

Event Problem Codes and Manufacturer Evaluation

What are the consequences of a recall?

MedWatch: Safety Information and AER Program

whether or not to get your product back?

Completing Form FDA 3500A

How do you prepare for a post recall inspection?

What form should I use to submit reports of

What customer and other outside communications

individual adverse events and where do I obtain

Where and how do I submit reports and additional

How should the product liability implications of

recall communications be handled?

Does the information in my report constitute an

What is an effectiveness check?

admission that the device caused or contributed to

Health Hazard Evaluations are conducted by FDA

the reportable event?

How should you write your recall correspondence?

What are the requirements for developing,

How do you determine that your recall is completed